NCT01700283

Brief Summary

The aims of this four-year study are to

  1. 1.Explore exercise behavior, exercise barriers, and identify the significant factors for exercise behavior in colorectal cancer survivors.
  2. 2.Explore the relationships among fatigue, muscle strength, and metabolomics and further examine the possible biomarkers from muscle strength and metabolomics for fatigue.
  3. 3.Develop a clinical guidelines of home-based fatigue management and exercise program and test its effect on decreasing fatigue for patients with colorectal cancer after surgery in Taiwan.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
306

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 14, 2012

Status Verified

October 1, 2012

Enrollment Period

2.7 years

First QC Date

October 2, 2012

Last Update Submit

November 12, 2012

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer、Fatigue、Muscle strength、Metabolomics

Outcome Measures

Primary Outcomes (1)

  • Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors

    Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.

    four-year study

Study Arms (2)

exercise education and walking program

EXPERIMENTAL
Behavioral: exercise education and walking program

maintain their daily activity

NO INTERVENTION

Interventions

exercise education and walking programBEHAVIORAL

12-week moderate intensity walking program

exercise education and walking program

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer survivors completed treatment at least 3 months in clinics.
  • Aged above 20.

You may not qualify if:

  • KPS \< 60
  • Stage 4
  • Bone meta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Shiow-Ching Shun, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiow-Ching Shun, PHD

CONTACT

886-2-23123456scshun@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 14, 2012

Record last verified: 2012-10

Locations

TW(1)